JPRN-jRCT2071200078CompletedPhase 2
A randomized double-blind placebo controlled phase 2 clinical trial to assess anti-inflammatory effect of colchicine (DRC3633) in mild to moderately severe COVID-19 patients. - DRC-06C
Kinjo Takeshi0 sites70 target enrollmentStarted: January 7, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •(1) Patients with a definitive diagnosis of COVID-19 and written informed consent.
- •(2) Patients with oxygen saturation of more than 94% at room air and having either or both of the following:
- •a. Pneumonia shadow on chest imaging
- •b. Having more than one risk factors of the followings:
- •Diabetes mellitus, Cardiovascular disease (coronary disease, stroke, peripheral arterial disease, heart failure), Chronic obstructive pulmonary disease, chronic kidney disease (30 <= eGFR < 60), Obesity (BMI >= 30), Elderly (age >= 65 )
- •(3) Patients hospitalized within 5 days after the onset of symptoms and with the ability of administrating the investigational drug by the second day of hospitalization
- •(4) Adult patients aged more than 20 at informed consent
- •(5) Patients or partners of patients agreed to prevent pregnancy for 90 days from the day of initiating investigational drug
- •(6) Patients being able to understand and willing to sign an IRB approved written informed consent document
Exclusion Criteria
- •(1)Asymptomatic patients
- •(2)Patients previously diagnosed COVID-19 in the past
- •(3)Known allergy or intolerance to colchicine
- •(4)Patients taking colchicine withing the past 30 days of consent date
- •(5)Patients taking biological drug withing the past 30 days of consent date
- •(6)Patients taking oral or intravenous corticosteroids withing the past 30 days of informed consent date
- •(7)Liver cirrhosis
- •(8)Clinical cholestasis
- •(9)Renal failure (eGFR < 30)
- •(10)Active or previous history of malignant disease
- •(11)Patients taking medicines as listed below:
- •a.Medicines strongly inhibiting CYP3A4
- •Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Ritonavir, Saquinavir, Darunavir, Telithromycin, Telaprevir, drugs containing kobishistat
- •b.Medicines moderately inhibiting CYP3A4
- •Amprenavir, Aprepitant, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Verapamil
- •c.Medicines inhibiting P glycoprotein
- •Cyclosporine
- •(12)Patients taking Amiodarone or Quinidine
- •(13)Pregnant or possibly pregnant patients, patients with breastfeeding, patients willing to be pregnant
- •(14)Patients registered in other clinical trials/studies at informed consent date or in the past 30 days of informed consent date
- •(15)Patients being considered as inappropriate by attending physicians
Investigators
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